# K182571: CardioFlux with Faraday Analytical Cloud

- Pathway: 510(k) (Traditional)
- Applicant: Genetesis, Inc.
- Decided: Mar 15, 2019 after 178 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K901215 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151135: Model 621/624 Biomagnetometer, Tristan Technologies, Inc. (2016) Summary page 4.

## Indications for use
The CardioFlux FAC Magnetocardiograph is intended for use as a tool which non-invasively measures and displays the magnetic signals produced by the electric currents of the heart.

Source page: https://510kreport.com/device/K182571
Methodology: https://510kreport.com/methodology